Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care <i>verSus</i> usual Care On ICU PErformance (TELESCOPE) trial

Ranzani, Otavio; Pereira, Adriano José; Santos, Maura Cristina dos; Corrêa, Thiago Domingos; Ferraz, Leonardo Jose Rolim; Cordioli, Eduardo; Morbeck, Renata Albaladejo; Berwanger, Otávio; Morais, Lúbia Caus de; Schettino, Guilherme; Cavalcanti, Alexandre Biasi; Rosa, Regis Goulart; Biondi, Rodrigo Santos; Salluh, Jorge Ibrain Figueira; Azevedo, Luciano César Pontes de; Serpa Neto, Ary; Noritomi, Danilo Teixeira

doi:10.5935/0103-507x.20220003-en

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SPECIAL ARTICLE • Rev. bras. ter. intensiva 34 (01) • Jan-Mar 2022 • https://doi.org/10.5935/0103-507x.20220003-en copy

Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care.

Methods:

The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia.

Conclusion:

According to the trial’s best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results.

ClinicalTrials.gov registration: NCT03920501

Keywords:
Length of stay; Patient care team; Research design; Data interpretation, statistical; Telemedicine; Hospital mortality; Critical care; Intensive care units; Brazil

Outcome	Description
Primary outcome
Patient level	ICU LOS, measured in days, considering the time interval in hours between patients’ ICU admission and ICU discharge times (i.e., transfer to another care facility or another hospital) or ICU death, as defined by the hospital’s system date and time. Date and time will be entered by the health care worker responsible for data collection. ICU LOS will be derived in 24 hours periods with decimal places, as recommended(¹²12 Harhay MO, Ratcliffe SJ, Small DS, Suttner LH, Crowther MJ, Halpern SD. Measuring and analyzing length of stay in critical care trials. Med Care. 2019;57(9):e53-9.)
Secondary exploratory outcomes
Unit level	Classification of the unit according to the profiles defined by the SRU and the SMR.(¹³13 Rapoport J, Teres D, Lemeshow S, Gehlbach S. A method for assessing the clinical performance and cost-effectiveness of intensive care units: a multicenter inception cohort study. Crit Care Med. 1994;22(9):1385-91.,¹⁴14 Rothen HU, Stricker K, Einfalt J, Bauer P, Metnitz PG, Moreno RP, et al. Variability in outcome and resource use in intensive care units. Intensive Care Med. 2007;33(8):1329-36.) The SRU reflects the observed/expected rate of resources used (estimated as ICU length of stay for surviving patients), adjusted by the patient’s severity of illness (SAPS 3).(¹⁵15 Moreno RP, Metnitz PG, Almeida E, Jordan B, Bauer P, Campos RA, Iapichino G, Edbrooke D, Capuzzo M, Le Gall JR; SAPS 3 Investigators. SAPS 3--From evaluation of the patient to evaluation of the intensive care unit. Part 2: Development of a prognostic model for hospital mortality at ICU admission. Intensive Care Med. 2005;31(10):1345-55.) The SMR reflects the observed/expected rate (according to severity score) of hospital deaths. The profiles are a combination of SMR (above or below median) and SRU (above or below median): Each unit can be assigned to one of the four groups: “most efficient” (SMR and SRU < median); “least efficient” (SMR, SRU > median); “overachieving” (low SMR, high SRU), “underachieving” (high SMR, low SRU)(¹⁴14 Rothen HU, Stricker K, Einfalt J, Bauer P, Metnitz PG, Moreno RP, et al. Variability in outcome and resource use in intensive care units. Intensive Care Med. 2007;33(8):1329-36.)
Individual level	In-hospital mortality, defined as death by any cause, within the period from the date of ICU admission to the date of hospital discharge or death, whichever comes first Incidence of CLABSI, as defined by the CDC(¹⁶16 Centers for Disease Control and Prevention (CDC). National Healthcare Safety Network (NHSN). Bloodstream Infection Event (Central LineAssociated Bloodstream Infection and Non-central Line Associated Bloodstream Infection). 2018. Available from: https://www.cdc.gov/nhsn/PDFs/pscManual/4PSC_CLABScurrent.pdf https://www.cdc.gov/nhsn/PDFs/pscManual/... ) Incidence of VAE, as defined by the CDC(¹⁷17 Centers for Disease Control and Prevention (CDC). National Healthcare Safety Network (NHSN). Pneumonia (Ventilator-associated [VAP] and non-ventilator-associated Pneumonia [PNEU]) Event. [Internet]. 2018. Available from: https://www.cdc.gov/nhsn/pdfs/pscmanual/6pscvapcurrent.pdf https://www.cdc.gov/nhsn/pdfs/pscmanual/... ) Incidence of CAUTI, as defined by the CDC(¹⁸18 Centers for Disease Control and Prevention (CDC). National Healthcare Safety Network (NHSN). Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and Non-Catheter-Associated Urinary Tract Infection [UTI]) and Other Urinary System Infection [USI]) Events. [Internet]. 2018. Available from: https://www.cdc.gov/nhsn/pdfs/pscmanual/7psccauticurrent.pdf https://www.cdc.gov/nhsn/pdfs/pscmanual/... ) Ventilator-free days at 28 days, defined as the number of days from successfully weaning to Day 28; patients who died before weaning were deemed to have no ventilator-free days Rate of patients receiving oral or enteral feeding, defined as any amount of oral or enteral diet, during ICU stay Rate of patients under light sedation or alert and calm [RASS =-3 to +1] Rate of patients under normoxemia SpO₂ between 92% and 96%
Other exploratory outcomes	ICU mortality 24-hour ICU readmission rate Proportion of MV use Early reintubation rate (< 48 hours after extubation) Accidental extubation rate Rate of patients with head of bed elevation for patient under MV Rate of CVC use and duration Rate of urinary catheter use and duration Rate of adequate prevention of VTE Rate of patients with adequate glycemic control

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[1] Conflicts of interest: None.